CurrentMass General Brigham Health PlanPolicy N/A

Adbry (tralokinumab-ldrm)

Pharmacy benefit prior authorization policy for Adbry (tralokinumab-ldrm) for treatment of moderate-to-severe atopic dermatitis in members >=12 years; defines initial and continuation criteria, quantity limits, specialty dispensing, and documentation requirements.

Policy Summary

PayerMass General Brigham Health Plan

PolicyAdbry (tralokinumab-ldrm)

Policy CodePolicy N/A

Change TypeClarified documentation; prior substantive revisions noted

Effective DateMay 1, 2026

Next Review Date

Key ActionPrior authorization is required under the Pharmacy Benefit for Adbry; initial approvals granted for 6 months and reauthorizations for 12 months.

SourceLink

POLICY UPDATE CHANGES

Administrative update changing reauthorization verbiage to 'submission of medical records (e.g., chart notes...)' and updating language for members new to the Plan.

Updated initial approval length to 6 months (03/12/2025) and reauthorization criteria to require documentation of clinical response (01/08/2025).

Updated age requirement from 18 to 12 years (09/11/2024) and added quantity limit for 300 mg/mL (effective 11/01/2024).

>=12Minimum age (years)

6 monthsInitial approval length

12 monthsReauthorization length

Formulations with quantity limits

Coverage Summary

Covered with criteria: Adbry (tralokinumab-ldrm) is covered under the Pharmacy Benefit for treatment of moderate-to-severe atopic dermatitis in patients >= 12 years. Therapy may be used with or without topical corticosteroids. Prior authorization is required; initial approvals are granted for 6 months with reauthorizations for 12 months. This medication is designated specialty and must be dispensed through a contracted specialty pharmacy. Quantity limits apply by strength: Adbry 150 mg/mL: 4 injections per 28 days and Adbry 300 mg/mL: 2 injections per 28 days.

Key thresholds, trials, and approval lengths

BSA / crucial areas>= 10% BSA OR involvement of crucial body areas (hands, feet, face, neck, scalp, genitals/groin, intertriginous areas)

Topical therapy trial length>= 30 days for listed agents; 14 days for topical corticosteroids

Initial approval length6 months

Reauthorization length12 months

Formulation quantity limitsAdbry 150 mg/mL: 4 injections per 28 days; Adbry 300 mg/mL: 2 injections per 28 days

Initial Therapy Criteria (New or Existing Members)

Continuation Therapy Criteria (Reauthorization)

Limitations and Administration

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required under the Pharmacy Benefit for Adbry. Initial approvals are granted for 6 months and reauthorizations are granted for 12 months.

Documentation Required

Documentation for new-to-plan members

If the member is new to the plan (coverage effective date ≤ 90 days), submit medical records documenting that the member is currently receiving Adbry. Do not include samples or medications obtained via manufacturer's patient assistance programs.

Applicable Codes

Benefit / Program Typemixed

Pharmacy Benefit

Covered under Pharmacy Benefit; prior authorization required

Clinical Evidence

Evidence: Adbry (tralokinumab-ldrm) prescribing information (Adbry [prescribing information], LEO Pharma Inc.; December 2025) is the source for the labeled indication and dosing.

Background

Adbry is an interleukin-13 (IL-13) antagonist indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. It may be used with or without topical corticosteroids. The policy defines initial and continuation criteria that include topical therapy step requirements (minimum trial lengths) and an Appendix listing topical corticosteroid potencies. The policy also requires specialty pharmacy dispensing and includes quantity limits by formulation.

Crucial body areas: Hands, feet, face, neck, scalp, genitals/groin, intertriginous areas

Revision History

09/11/2024material

Age requirement updated from 18 to 12 years (effective 11/01/2024).

11/01/2024material

Quantity limit added for Adbry 300 mg/mL strength (policy reflected addition of quantity limits).

01/08/2025material

Reauthorization criteria revised to require documentation of clinical response to therapy (effective 04/01/2025).

Policy Summary

PayerMass General Brigham Health Plan

PolicyAdbry (tralokinumab-ldrm)

Policy CodePolicy N/A

Change TypeClarified documentation; prior substantive revisions noted

Effective DateMay 1, 2026

Next Review Date

Key ActionPrior authorization is required under the Pharmacy Benefit for Adbry; initial approvals granted for 6 months and reauthorizations for 12 months.

SourceLink

On This Page

Documentation Required

Documentation for reauthorization

For reauthorization, submit medical records (e.g., chart notes) demonstrating clinical improvement in the member's condition, for example clear or almost clear skin or improvement in signs and symptoms (redness, itching, oozing/crusting).

Billing Rule

Specialty pharmacy dispensing

This medication is designated specialty and must be dispensed through a contracted specialty pharmacy.

Billing Rule

Quantity limits

Quantity limits apply by strength: Adbry 150 mg/mL — 4 injections per 28 days; Adbry 300 mg/mL — 2 injections per 28 days.

03/12/2025material

Initial approval length updated to 6 months (effective 04/01/2025).

05/01/2026administrativeLatest

Administrative clarification: wording changed in reauthorization verbiage to 'submission of medical records (e.g., chart notes...)' and updated language for members new to the Plan; no clinical policy changes.